FDA Orange Book · active-ingredient family
Inotersen sodium
Inotersen sodium is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:TEGSEDI · NDA 211172
1
Brand (NDA)
0
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| TEGSEDIRLD | AKCEA THERAPS | NDA 211172 | — | Oct 05, 2018 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9399774 | Apr 29, 2031 | in 4 yr 11 mo | U-2430 |
| 9061044 | Apr 29, 2031 | in 4 yr 11 mo | Substance |
| 8697860 | Apr 29, 2031 | in 4 yr 11 mo | Product |
Inotersen sodium — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
